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Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma

NCT00134030 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1334

Last updated 2023-06-07

Study results available
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Summary

This randomized phase III trial is studying combination chemotherapy followed by surgery and two different combination chemotherapy regimens with or without PEG-interferon alfa-2b to compare how well they work in treating patients with osteosarcoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Biological therapies, such as PEG-interferon alfa-2b, may interfere with the growth of tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so it can be removed. Giving combination chemotherapy together with PEG-interferon alfa-2b after surgery may kill any remaining tumor cells. It is not yet known whether giving combination therapy together with PEG-interferon alfa-2b is more effective than two different combination chemotherapy regimens alone after surgery in treating osteosarcoma.

Conditions

  • Localized Osteosarcoma
  • Metastatic Osteosarcoma

Interventions

DRUG

Cisplatin

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

DRUG

Ifosfamide

Given IV

DRUG

Methotrexate

Given IV

BIOLOGICAL

Peginterferon Alfa-2b

Given subcutaneously

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Therapeutic Conventional Surgery

Undergo amputation or limb salvage surgery

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University College, London

    collaborator OTHER

  • Medical Research Council

    collaborator OTHER_GOV

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Neyssa M Marina · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-14
Primary Completion
2015-01-31
Completion
2022-09-30

Countries

  • United States
  • Australia
  • Canada
  • New Zealand
  • Puerto Rico
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00134030 on ClinicalTrials.gov